QbD in Pharma Development
|Event Date/Time: Feb 24, 2014||End Date/Time: Feb 25, 2014|
|Early Registration Date: Nov 29, 2013|
We are delighted to announce the 2nd International conference on “QbD in Pharma Development” with the theme "Excellence and Compliance using QbD". This event is especially designed to discuss the implementation case studies, success stories and issues and challenges faced while implementing QbD principles at industry level.
The federal agencies have reiterated to build quality into the products during multi-phase product development life cycle and eventually, enhance product and/or process understanding, all using the rational and systematic approach of QbD. The key elements of QbD including the QTPP, CQAs, QRM, CMA, CPP and control strategy, as enumerated in the ICH guidelines, Q8, Q9, Q10 and Q11, are to be followed and implemented. The key regulatory agencies across the globe like US FDA, WHO, EMEA, Health Canada, MHA, TGA, PMDA and SFDA have adopted such ICH guidance per se. Besides being a federal requirement, QbD is fast emerging as a tangible tool to quicken time to reach market, reduce recalls and rejects, improve patient generic scepticism, minimise post-approval changes, streamline data flows across the entire life cycle of the drug, and above all, improve overall efficacy and cost-efficacy for patients and manufacturers alike.
- Design Space Considerations: Where are We Currently?
- DoE & Multivariate FbD Strategies for Product and Process Understanding
- Implementation of QbD in API Development
- QbD Applications in Developing NDDS and Biologics
- QbD Case studies in the Light of Federal Perspectives
- QbD for Optimizing Excipient Attributes
- QbD Implementation in Product Development: Formulation by Design (FbD)
- QbD in Product Life Cycle: Emerging Challenges and Issues
- Quality Risk Management (QRM) tools during QbD Execution
- Systematic QbD Approaches in Analytical Method Development
Ranjit Barshikar QbD/cGMP Consultant, Pharma Quality Management Consultants
Bhupinder Bhoop Professor, Panjab University
Brian Carlin Director, FMC Corporation
Mukesh Gohel Former Principal and Professor, L M College of Pharmacy
This event will offer definitive benefits to the scientists from academia and industry working in the domains of Product Development, Process R & D, Scale-up, Manufacturing, Quality Assurance, Global Regulatory Affairs, API, Excipients, Pharmaceutical Analysis and Technology Transfer. The speakers will articulate on all the pertinent areas of QbD Implementation including API, Analytical Development, Excipients and Formulation.
Running alongside the conference will be our “Generics and Biologics 2014” meeting.